Rules for Recommending at the CVX Code vs. Vaccine Group Level 

• If the patient has no shots on record, 
  • and is < 6 months old, recommend at the vaccine group level with recommendation reason at 6 months of age.
  • otherwise, recommend at the vaccine group level at today’s date.
• If the patient has shots on record and the series is not complete,
  • and is < 6 months old, recommend at the vaccine group level at 6 months old, or at the recommended interval, whichever date is later.
  • otherwise, recommend at the vaccine group level at the recommended due date.

Series Completion Special Rule

• Once a patient completes:
  • a COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a COVID-19 vaccine series not authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine, 
    • recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (5 months) or at recommended age (12 years), whichever date is later, along with recommendation reason code BOOSTER_DOSE.  
    • and receives an additional dose1 (see “Rules for Additional Dose” for information on what constitutes an additional dose and how is evaluated), the Recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.

    • See “Rules for Booster Dose” for booster dose recommendations for the these series.

  • the Moderna COVID-19 Series,
    • and is < 5 years old, the recommendation is Not Recommended and the reason code is COMPLETE.
    • and is < 18 years old, the recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK. 

    • and is >= 18 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (5 months) or at recommended age (18 years), whichever date is later, along with recommendation reason code BOOSTER_DOSE

    • and receives an additional dose¹ (see “Rules for Additional Dose” for information on what constitutes an additional dose and how is evaluated), the Recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.

    • See “Rules for Booster Dose” for booster dose recommendations for the Moderna COVID-19 (5-17) 2-dose Series.

  • the Pfizer COVID-19 Series or Mixed Product Series
    
    • and is < 5 years old, the recommendation is Not Recommended and the reason code is COMPLETE.
    • and is >= 5 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (5 months) or at recommended age (5 years), whichever date is later, along with recommendation reason code BOOSTER_DOSE
    • and receives an additional dose¹, the Recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK.
    • and receives a booster dose², the Recommendation is Not Recommended and the reason code is COMPLETE.
  • the Janssen COVID-19 1-dose series, 
    • and is >= 12 years old, recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (8 weeks), along with recommendation reason code BOOSTER_DOSE.  
    • and is < 12 years old, the recommendation is Conditional and the reason code is COMPLETE_HIGH_RISK. 

    • See “Rules for Booster Dose” for booster dose recommendations for the Janssen COVID-19 1-dose series.

Rules for an Additional Dose¹

• If a patient completes a COVID-19 vaccine series via the Pfizer COVID-19 series, Moderna COVID-19 series, COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a COVID-19 vaccine series not authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine and receives an additional shot of CVX 207, CVX 208, CVX 213, CVX 217, CVX 218, CVX 219, CVX 227 or CVX 228:
  
  • at < 5 months after series completion, then evaluate the shot as Valid/ SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum interval of 5 months required for the 1st Booster Dose."
  • at >= 5 months after series completion, then evaluate the shot as Valid. 

• If a patient is >= 5 years old, completes a COVID-19 vaccine series via the Pfizer COVID-19 (5-17) 2-dose series and receives an additional shot of CVX 218, CVX 208, CVX 217, CVX 207, or CVX 213:
• at < 28 days after series completion, then evaluate the shot as Valid/ SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum interval of 28 days required for an Additional Dose for immunocompromised patients or the minimum interval of 5 months required for a Booster Dose."
• at >= 28 days and < 5 months after series completion, then evaluate the shot as Valid/ SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum interval of 5 months required for a Booster Dose."
• at >= 5 months after series completion, then evaluate the shot as Valid. 

• If a patient completes a COVID-19 vaccine series via the Janssen 1-dose series and receives an additional shot of CVX 207, CVX 208, CVX 213, CVX 217, CVX 218, CVX 219, CVX 227 or CVX 228:

  • at < 8 weeks after series completion, then evaluate the shot as Valid/ SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum interval of 8 weeks required for the 1st Booster Dose"

  • at >= 8 weeks after series completion, then evaluate the shot as Valid. 

Rules for Booster Dose²

Any of the FDA-Approved COVID-19 vaccines (except CVX 218) can be used for booster vaccination, regardless of the vaccine product used for primary vaccination. When a heterologous or “mix and match” booster dose is administered, the eligible population and dosing intervals are those of the vaccine used for primary vaccination.

Recommendation Rules for Booster Dose

• Recommend at the Vaccine Group Level (along with recommendation reason code BOOSTER_DOSE)

• First Booster Dose

  • After completion of a COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a COVID-19 vaccine series not authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine

    • Recommended Age = 12 years

    • Minimum Age = 12 years

    • Recommended Interval = 5 months

    • Include recommendation reason Code ADMINISTER_mRNA_VACCINE (new reason code)

  • After completion of the Moderna COVID-19 Series

    • Recommended Age = 18 years

    • Minimum Age = 18 years

    • Recommended Interval = 5 months

  • After completion of the Pfizer COVID-19 Series or Mixed Product Series

    • Recommended Age = 5 years

    • Minimum Age = 5 years

    • Recommended Interval = 5 months

  • After completion of Janssen 1-dose series

    • Recommended Age = 12 years

    • Minimum Age = 12 years

    • Recommended Interval = 8 weeks

• 2nd Booster Dose:

  • After completion of the first booster in the Pfizer Series, Moderna Series, Mixed Product Series, a COVID-19 vaccine series not authorized by the FDA but authorized by the WHO, or a COVID-19 vaccine series not authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine:

    • If the patient is < 50 years of age, recommend Conditional / COMPLETE_HIGH_RISK.

    • Otherwise:

      • Minimum Age = 50 years

      • Recommended Age = 50 years

      • Recommended Interval = 4 months

  • After completion of first booster dose in the Janssen series:

    • If the patient >= 12 years of age and < 18 years of age:

      • Recommend Conditional / COMPLETE_HIGH_RISK

    • If the patient >= 18 years of age:

      • and <50 years:

        • Recommend Conditional / COMPLETE_HIGH_RISK if first booster dose was an mRNA vaccine (CVX 207, CVX 208, CVX 213, CVX 217 or CVX 221)

      • and >=50 years:

        • Recommended Age = 50 years if first booster dose was an mRNA vaccine (CVX 207, CVX 208, CVX 213, CVX 217, or CVX 221)

        • Recommended Age = 18 years if first booster dose was the Janssen vaccine (CVX 212)

        • Recommended Interval = 4 months

  • After completion of the 2nd booster dose² (must be mRNA), the Recommendation is Not Recommended and the reason code is COMPLETE.

Evaluation Rules for Booster Dose

• Any of the FDA-Approved COVID-19 vaccines (except CVX 218) are allowed for both Booster Doses.
• Absolute Minimum Interval = 0 days
• First Booster Dose:
  • If a patient completes a COVID-19 vaccine series via the Pfizer series, Moderna 2-dose series, COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a COVID-19 vaccine series not authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine and receives a Booster Dose² of CVX 207, CVX 208, CVX 212, CVX 213, CVX 217 or CVX 221: 
    • at < 5 months after series completion, then evaluate the shot as Valid/ SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum interval of 5 months required for a Booster Dose."
    • at >= 5 months after series completion, then evaluate the shot as Valid. 
  • If a patient completes a COVID-19 vaccine series via the Janssen 1-dose series and receives a Booster Dose² of CVX 207, CVX 208, CVX 212, CVX 213, CVX 217 or CVX 221:
    • at < 8 weeks after series completion, then evaluate the shot as Valid/ SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum interval of 8 weeks required for a Booster Dose."
    • at >= 8 weeks after series completion, then evaluate the shot as Valid.
• Second Booster Dose:

  • If a patient completes a COVID-19 vaccine series via the Pfizer COVID Series, Moderna COVID Series, Janssen 1-dose series, COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a COVID-19 vaccine series not authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine and receives a Booster Dose² of CVX 208, CVX 217, CVX 207, CVX 212, CVX 213 or CVX 221: 

    • at < 4 months after the first booster dose, then evaluate the shot as Valid / SUPPLEMENTAL_TEXT; Descriptive Text: “"The timing of the administration of this shot does not follow the guidelines regarding the minimum interval of 4 months required for the 2nd Booster Dose."

    • at >= 4 months after the first booster dose, evaluate the shot as Valid.

Rules for Extra Shots After Additional Dose¹and/or Booster Doses²

• In the Pfizer COVID-19 Series and Mixed Product COVID-19 Series:

  • is < 5 years old, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

  • is > = 5 years old and < 50 years old and received an Additional Dose and/or Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 

  • is >= 50 years of age and Additional Dose and/or Booster Dose, and 2nd Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

  • and Additional Dose and/or 1st Booster Dose and 2nd Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE

• For patients that completed the Moderna COVID-19 2-dose series:

  • is < 5 years old, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE

  • is >= 5 years old and < 18 years old and received an Additional Dose, any shots administered afterwards at < 18 years of age will be evaluated as Accepted/EXTRA_DOSE

  • is > = 18 years old and < 50 years old and received an Additional Dose and/or Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 

  • is >= 50 years of age and Additional Dose and/or Booster Dose, and 2nd Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

  • and Additional Dose and/or 1st Booster Dose and 2nd Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

• For patients that completed Janssen COVID-19 1-dose series:

  • is < 5 years old, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

  • is > = 5 years old and < 50 years old and received an Additional Dose and/or Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE. 

  • is >= 50 years of age and Additional Dose and/or Booster Dose, and 2nd Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

  • and Additional Dose and/or 1st Booster Dose and 2nd Booster Dose, any shots administered afterwards will be evaluated as Accepted/EXTRA_DOSE.

• For patients that completed either the 1) COVID-19 vaccine series not authorized by the FDA, but authorized by the WHO, or a 2) COVID-19 vaccine series not authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine, Additional Dose and/or first Booster Dose, and 2nd booster dose, any shots administered after the primary series is evaluated as Accepted/EXTRA_DOSE.

Notes

• ¹Additional Dose - Defined by ACIP to be a dose administered when the immune response to a standard primary vaccine series is likely not to be protective. 
• ²Booster Dose - Defined by ACIP to be a dose administered to restore protection after the effectiveness of protection from the primary series has declined. 

CVX Code Specific Rules

CVX Code Absolute Minimum Age

• If one of the CVX codes in the table above is administered below the absolute minimum age for that CVX code, then the Evaluation is Invalid and the reason code is BELOW_MINIMUM_AGE_VACCINE

CVX Code Absolute Maximum Age

• If one of the CVX codes in the table above is administered above the absolute maximum age for that CVX code, then the Evaluation is Invalid and the reason code is ABOVE_MAXIMUM_AGE_VACCINE.

Absolute Minimum Interval Rule for Moderna Vaccines

• The absolute minimum interval between a previously administered Moderna vaccine and the next shot is 24 days.

Rule for CVX 213

• If the patient receives CVX 213 for:
  • Target Dose 1, evaluate the shot as Valid.
    • Recommended interval = 28 days
    • Recommended age = 6 months
      
  • Target Dose 2, evaluate the shot as Valid. 
  • If the patient receives CVX 213 for Target Dose 1 and CVX 212 (Janssen COVID-19 Vaccine) is reported for Target Dose 2, the Janssen COVID-19 1-dose Series applies and the series is complete. Therefore,  
    • evaluate Target Dose 2 (CVX 212) as Valid.
    • evaluate Target Dose 1 as Accepted and the reason code is VACCINE_NOT_COUNTED_BASED_ON_MOST_RECENT_VACCINE_GIVEN.

Rules for COVID-19 Vaccines Not Authorized by FDA²

The following set of rules apply to 1) COVID-19 Vaccines Not Authorized by FDA, but Authorized by WHO and, 2) COVID-19 Vaccines Not Authorized by FDA or WHO, but is an Active COVID-19 Vaccine Candidate as part of a U.S.-based Clinical Trial of a COVID-19 Vaccine. 

• The list of COVID-19 Vaccines Not Authorized by the FDA, but Authorized by the WHO are:

  • CVX 210 - AstraZeneca COVID-19 Vaccine

  • CVX 510 - BIBP, Sinopharm COVID-19 Vaccine
  • CVX 511 - CoronaVac, Sinovac
  • CVX 502 - COVAXIN
  • CVX 211- Novavax COVID-19 Vaccine

  • CVX 512 - COVID-19 VLP Non-US Vaccine (Medicago, Covifenz)

• The list of COVID-19 Vaccines Not Authorized by the FDA or WHO, but is an active COVID-19 vaccine candidate as part of a U.S.-based clinical trial of a COVID-19 vaccine are:

  • Note - Currently, there are no COVID-19 vaccines that fall into this category. 
• If the patient has received all recommended doses of the COVID-19 vaccine, then: 
  • Evaluate the shots as Valid; (Absolute Minimum Interval = 0 days; Absolute Minimum Age = 0 days)
  • Recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (5 months), along with recommendation reason code BOOSTER_DOSE.  
• If the patient has received one or more doses, but has not received all the recommended doses for that COVID-19 vaccine, then:
  • Evaluate the shot(s) as Valid.
  • Recommendation:
    • If one of the above listed COVID-19 vaccine is the last COVID-19 shot administered, then recommend COVID-19 at the vaccine group level at last shot administered + recommended interval (28 days) or at 5years old, whichever date is later, in addition to returning recommendation reason code SUPPLEMENTAL_TEXT; Descriptive Text: "The vaccine administered should be a single dose of a Pfizer COVID-19 vaccine."
    • Once the patient has received the recommended COVID-19 vaccine, the series is complete. Recommend a booster dose of COVID-19 (at vaccine group level) at recommended interval (5 months), along with recommendation reason code BOOSTER_DOSE. 

• The list of COVID-19 Vaccines Not Authorized by the FDA or WHO are:

  • CVX 500 - COVID-19 Non-US Vaccine, Product Unknown 
  • CVX 501 - COVID-19 IV Non-US Vaccine (QAZCOVID-IN)
  • CVX 503 - COVID-19 LAV Non-US Vaccine (COVIVAC) 
  • CVX 504 - COVID-19 VVnr Non-US Vaccine (Sputnik Light) 
  • CVX 505 - COVID-19 VVnr Non-US Vaccine (Sputnik V)
  • CVX 506 - COVID-19 VVnr Non-US Vaccine (CanSino Biological Inc./Beijing Institute of Biotechnology)
  • CVX 507 - COVID-19 PS Non-US Vaccine (Anhui Zhifei Longcom Biopharmaceutical + Institute of Microbology Chinese academy of Sciences)
  • CVX 508 - COVID-19 PS Non-US Vaccine (Jiangsu Province Centers for Disease Control and Prevention)
  • CVX 509 - COVID-19 PS Non-US Vaccine (EpiVacCorona)

  • CVX 513 - COVID-19 PS Non-US Vaccine (Anhui Zhifei Longcom, Zifivax)

  • CVX 514 - COVID-19 DNA Non-US Vaccine (Zydus Cadila, ZyCoV-D)

  • CVX 515 - COVID-19 PS Non-US Vaccine (Medigen, MVC-COV1901)

  • CVX 516 - COVID-19 Inactivated Non-US Vaccine (Minhai Biotechnology Co, KCONVAC)

  • CVX 517 - COVID-19 PS Non-US Vaccine (Biological E Limited, Corbevax)

• If the patient has received a COVID-19 vaccine not authorized by the FDA or WHO for all or some or the recommended doses of the COVID-19 vaccine, then: 
  • Evaluate the shot(s) as Invalid/ VACCINE_NOT_APPROVED_IN_US_OR_BY_WHO. 
  • Recommendation:
    • If one of the above listed COVID-19 vaccine is the last COVID-19 shot administered, then recommend COVID-19 at the vaccine group level at last shot administered + recommended interval (28 days) or at 5 years old, whichever date is later.  
      • Example #1: Patient has 1 shot of CVX 501 on record.
        • Evaluate CVX 501 as Invalid/ VACCINE_NOT_APPROVED_IN_US_OR_BY_WHO.
        • Recommend COVID-19 at the vaccine group level for Target Dose 1 at CVX 501 + recommended interval (28 days). 
      • Example #2: Patient has 1 shot of CVX 208 (Pfizer), then 1 shot of CVX 501 on record. 
        • Evaluate CVX 208 as Valid and CVX 501 as Invalid/ VACCINE_NOT_APPROVED_IN_US_OR_BY_WHO.
        • Recommend COVID-19 at the vaccine group level for Target Dose 2 at CVX 501 + recommended interval (28 days). 
    • If one of the above listed COVID-19 vaccine is NOT the last COVID-19 shot administered, recommend based on the series that applies for the last COVID-19 shot administered.
      • Example: If CVX 208 (Pfizer) is given after CVX 501, then recommend based on the Pfizer COVID-19 2-dose Series.

Notes

• ²Rules for COVID-19 Vaccines Not Authorized by FDA were created to handle all other COVID-19 vaccine shots reported on patient records. The ICE rules were created and sourced from published guidance from the CDC - Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. As CDC guidance for COVID-19 evolves, ICE will be updated as necessary.

Series Name

• Pfizer COVID-19 Series

• Moderna COVID-19 Series

• Mixed Product COVID-19 Series

• Janssen COVID-19 1-dose Series

Series Selection Rules

There are four series for this vaccine group: the Pfizer COVID-19 series, Moderna COVID-19 series, Mixed Product COVID-19 series and the Janssen COVID-19 1-dose series. The rules for determining which series applies are:

• If there are no doses on record, then the Mixed Product COVID-19 Series applies.

• If there are doses on record:

  • If dose 1 is CVX 212, then the Janssen COVID-19 1-dose series applies.

  • If all administered doses are a Pfizer vaccine, then the Pfizer COVID-19 Series applies.

  • If all administered doses are a Moderna vaccine, then the Moderna COVID-19 Series applies.

  • Otherwise, the Mixed Product COVID-19 Series applies.

Series Special Rules

• If the patient receives a shot at < 6 months old, evaluate the shot as Valid, with reason code SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum age."

Series Special Rules

Series Special Rules

• If the patient receives a shot at < 18 years - 4 days of age, evaluate the shot as Valid, with reason code SUPPLEMENTAL_TEXT; Descriptive Text: "The timing of the administration of this shot does not follow the guidelines regarding the minimum age and/or minimum interval."